FDA adds heart attack and stroke warning to some painkillers

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A generic image of Tylenol acetaminophen pills.

FDA adds heart attack and stroke warning to some painkillers

A generic image of Tylenol acetaminophen pills.

ATLANTA – The U.S. Food and Drug Administration (FDA) is calling on drug makers of some popular painkillers to strengthen their warning labels after a review of new safety information. The warning labels on non-aspirin nonsteroidal anti-inflammatory drugs, known as NSAIDs, must be udpated to identify an increased risk of a heart attack or stroke.

NSAIDs are typically given to relieve pain or fever that results from, but not limited to, arthritis, flu, headaches and menstrual cramps. Higher doses require a prescription, while lower doses are available over-the-counter. The warning applies to both. Brand names include Celebrex, Advil, Naprosyn, Aleve and Daypro, to name a few.

Bayer (manufacturer of Aleve) released a statement to CNN saying: “When taken as directed on the label, Aleve (naproxen sodium 220 mg) is a safe and effective pain reliever, used by millions of consumers since its introduction as an OTC product 20 years ago. Importantly, data collected for nearly 20 years indicates no signal (i.e. trend) for OTC naproxen sodium with regard to the occurrence of (cardiovascular) thrombotic and overall (cardiovascular) events.”

The statement added: “We will work with the FDA to incorporate additional label information as appropriate.”

Pfizer (manufacturer of Celebrex and Advil) released a statement saying: “For over 30 years, extensive consumer use and several clinical studies have shown that Ibuprofen, when used as directed, is a safe and effective over-the-counter pain reliever delivered in a lower strength than prescription ibuprofen.

“We are committed to patient safety, and we will work with the FDA to make sure that new safety information is appropriately added to our packaging/drug facts label so that consumers can continue to safely use our products.”

The FDA issued, what it calls a drug safety communication, saying the labels must include, “the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID. The risk appears greater at higher doses.” Additionally, labels should say that the risk is not limited to patients with heart disease, and that patients with heart disease have a higher risk. The FDA says there is not sufficient evidence to determine whether the risk is the same for all NSAIDs. There is also an increased risk for heart failure associated with these medications.

The risks for prescription NSAIDs are greater because they are higher dosages and prescribed for daily use. In contrast, over-the-counter NSAIDs are taken intermittently and at lower dosages and thus carry a lower risk.

The move comes after an advisory committee reviewed these medications and the associated risks for cardiovascular events in February 2014, and recommended a strengthened warning.

Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, agrees with the evidence that these drugs do increase a person’s risk for heart attack and stroke. He says the warning, though is vague but has to be because there is no good data to give consumers or doctors a definitive answer. “What patients need to know is, if you take the drugs, ‘What is my risk of heart attack?’ and that’s not known yet,” Nissen says. He blames this on the drugs being approved before current vigorous outcome data was required by the FDA.

Nissen told CNN, “the writing has been on the wall for a long time.” After all, he is no stranger to these concerns. His 2001 study was the first to raise a red flag over the drug Vioxx, a COX-2 inhibitor, made by Merck, that was pulled from the market. On the heels of that, another COX-2 inhibitor, Bextra, was withdrawn.

Fifteen years later there is still not a definitive answer.

“We don’t have any good data,” Nissen says. In search of that robust scientific data on the risk of these drugs and whether or not the risk varies between these drugs, he and a group of his colleagues have been following 24,000 patients since 2007 in a randomized clinical trial. The study participants are divided into three groups treated with ibuprofen, Celebrex, or naproxen. The patients nor the doctors know who is getting which drug. The Precision trial, as its called, is funded by Pfizer and results are expected next year.

Atlanta internist Dr. Anna Steinberg agrees that the FDA’s warning is too vague. She says doctors already avoid NSAIDs for patients with congestive heart failure or high blood pressure. For patients with no risk, “I am not going to tell them to stop taking these,” she says, adding that alternatives for pain relief other than acetaminophen are limited. She believes the FDA should have waited until it could offer more definitive guidance, saying this creates, “way to much room for mass hysteria.”

In the meantime, Nissen says the best advice for patients is “take these at the lowest dosages for the least amount of time that relieves symptoms.” He says people should not be afraid to take ibuprofen but if you have heart disease you should be more cautious.

The FDA advises patients who experience shortness of breath, chest pain, sudden numbness or weakness, or sudden slurred speech to seek immediate medical attention. Other side effects should be reported to the agency.